NCT00476320

Brief Summary

Myocardial deformation imaging allows analysis of myocardial viability in ischemic left ventricular dysfunction. This study will evaluate the predictive value of myocardial deformation imaging for improvement in cardiac function after revascularization therapy in comparison to contrast-enhanced cardiac magnetic resonance imaging (ceMRI). In 55 patients with ischemic left ventricular dysfunction, myocardial viability was assessed using pixel-tracking-derived myocardial deformation imaging and ceMRI to predict recovery of function at 9±2 months follow-up. For each left ventricular segment in a 16-segment model peak systolic radial strain will be determined from parasternal 2D echocardiographic views and the amount of late hyperenhancement (LE) and maximal thickness of myocardial tissue without LE using ceMRI. The hypothesis is that compared with segments showing functional improvement, those that failed to recover had lower radial strain and lower thickness without LE and higher LE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
Last Updated

May 22, 2007

Status Verified

May 1, 2007

First QC Date

May 21, 2007

Last Update Submit

May 21, 2007

Conditions

Myocardial Viability in Ischemic Left Ventricular DysfunctionPrediction for Improvement in Cardiac Function After Revascularization Therapy

Keywords

echocardiographymyocardial infarctionmagnetic resonance imagingrevascularizationviability

Interventions

Magnetic Resonance ImagingPROCEDURE
RevascularizationPROCEDURE
Echocardiography with myocardial deformation imagingPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ischemic left ventricular dysfunction scheduled for coronary revascularization

You may not qualify if:

  • Patients with acute coronary syndrome and poor echocardiographic windows

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWTH University Hospital

Aachen, 52057, Germany

Location

Related Publications (5)

  • Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.

    PMID: 17035253RESULT

  • Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53. doi: 10.1056/NEJM200011163432003.

    PMID: 11078769RESULT

  • Reisner SA, Lysyansky P, Agmon Y, Mutlak D, Lessick J, Friedman Z. Global longitudinal strain: a novel index of left ventricular systolic function. J Am Soc Echocardiogr. 2004 Jun;17(6):630-3. doi: 10.1016/j.echo.2004.02.011.

    PMID: 15163933RESULT

  • Becker M, Altiok E, Lente C, Otten S, Friedman Z, Adam D, Hoffmann R, Koos R, Krombach G, Marx N, Hoffmann R. Layer-specific analysis of myocardial function for accurate prediction of reversible ischaemic dysfunction in intermediate viability defined by contrast-enhanced MRI. Heart. 2011 May;97(9):748-56. doi: 10.1136/hrt.2010.210906. Epub 2011 Mar 17.

    PMID: 21415076DERIVED

  • Becker M, Lenzen A, Ocklenburg C, Stempel K, Kuhl H, Neizel M, Katoh M, Kramann R, Wildberger J, Kelm M, Hoffmann R. Myocardial deformation imaging based on ultrasonic pixel tracking to identify reversible myocardial dysfunction. J Am Coll Cardiol. 2008 Apr 15;51(15):1473-81. doi: 10.1016/j.jacc.2007.10.066.

    PMID: 18402903DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Michael Becker, PhD, MD

    RWTH Aachen University Hospital

    PRINCIPAL INVESTIGATOR

  • Rainer Hoffmann, Professor

    RWTH Aachen University Hospital

    STUDY CHAIR

  • Malte Kelm, Professor

    RWTH Aachen University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

August 1, 2004

Study Completion

April 1, 2007

Last Updated

May 22, 2007

Record last verified: 2007-05

Locations

DE(1)